FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
53217-172
11-digit product format
532170172
Labeler code
53217
Product ID
53217-172_491e087f-cc22-46cf-9407-0509c339fe9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-172-072020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-142020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-152020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-212020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-282020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-302020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-402020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-452020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-602020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
53217-172-902020-01-31C16284748780-19d75b9d0-ad77-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-172-07Phentermine Hydrochloride7 in 1 BOTTLETABLET71
53217-172-14Phentermine Hydrochloride14 in 1 BOTTLETABLET141
53217-172-15Phentermine Hydrochloride15 in 1 BOTTLETABLET151
53217-172-21Phentermine Hydrochloride21 in 1 BOTTLETABLET211
53217-172-28Phentermine Hydrochloride28 in 1 BOTTLETABLET281
53217-172-30Phentermine Hydrochloride30 in 1 BOTTLETABLET301
53217-172-40Phentermine Hydrochloride40 in 1 BOTTLETABLET401
53217-172-45Phentermine Hydrochloride45 in 1 BOTTLETABLET451
53217-172-60Phentermine Hydrochloride60 in 1 BOTTLETABLET601
53217-172-90Phentermine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-172-07EA - Each53217-172f4642eba-98bb-4c26-b381-d997b43e064612017-03-06
53217-172-14EA - Each53217-1721fadd8c4-6c44-4db6-9917-f5cd9ff35d3012017-03-06
53217-172-15EA - Each53217-1724dbdd7b9-0cd1-4190-99e1-c0c69a0ab96612017-03-06
53217-172-21EA - Each53217-172aca11cb4-e3d2-44d0-95b3-1bf124a7270a12017-03-06
53217-172-28EA - Each53217-172d9648433-a3b2-4621-993f-3125efe75b5112017-03-06
53217-172-30EA - Each53217-1724e89cd19-4ce6-4995-b296-cab7917d719212017-03-06
53217-172-40EA - Each53217-17233a83565-3f5d-4b7e-83cc-8d1be847cb1e12017-03-06
53217-172-45EA - Each53217-172499d6669-4183-4f29-85f9-a8a9baf6c5c112017-03-06
53217-172-60EA - Each53217-1729bf3caa1-915a-4c3d-b415-e51d6784923a12017-03-06
53217-172-90EA - Each53217-1721c06f721-aac5-427a-9f7c-37fa4f00ff8512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-172PHENTERMINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 10 package rows20170301_e2349567-64c5-4b70-a1c9-183da6601c4b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-172-07532170172077 in 1 BOTTLEHistorical
53217-172-145321701721414 in 1 BOTTLEHistorical
53217-172-155321701721515 in 1 BOTTLEHistorical
53217-172-215321701722121 in 1 BOTTLEHistorical
53217-172-285321701722828 in 1 BOTTLEHistorical
53217-172-305321701723030 in 1 BOTTLEHistorical
53217-172-405321701724040 in 1 BOTTLEHistorical
53217-172-455321701724545 in 1 BOTTLEHistorical
53217-172-605321701726060 in 1 BOTTLEHistorical
53217-172-905321701729090 in 1 BOTTLEHistorical